Recruiting

ACL Reconstruction

Sponsor:

Marshall University

Code:

NCT06294314

Conditions

Anterior Cruciate Ligament Rupture

Eligibility Criteria

Sex: All

Age: 14 - 26

Healthy Volunteers: Accepted

Interventions

Fertilized ACL

Study Details

Brief summary:

The Investigators are studying the effect of an ACL reconstruction on return to play by capturing outcome measures and biomechanics information.

Conditions

Anterior Cruciate Ligament Rupture

Study ID

NCT06294314

Start date

Feb 26, 2024

Status verified date

Feb, 2024

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 26

Healthy Volunteers: Accepted

Inclusion Criteria:

  • INCLUSION CRITERIA: All patients must meet the following criteria:

  • Patients must be age 14-26 years old.
  • Skeletally mature patients, with an ACL deficient knee who desire to have ACL reconstructive surgery using autograft augmentation.
  • Patients must be a tanner stage of 5 and a posteroanterior left hand film x-ray will be obtained to confirm bone age and skeletal maturity
  • Patients with associated meniscal and chondral pathology (except patients falling into exclusion criteria below) will be included in the study; such pathology will be treated at the time of ACL reconstruction at the discretion of the surgeon, and such pathology and treatment will be recorded.
  • An understanding of the purpose of the study and providing written informed consent.

Exclusion Criteria:

  • EXCLUSION CRITERIA:

  • Patients with multi-ligament surgery (MCL, PCL, LCL, PMC, or PLC repair or reconstruction),
  • Patients who have undergone previous ACL reconstructive surgery.
  • Patients who are currently pregnant or nursing.
  • Patients who have a current infection at the operative site.
  • Any condition or personal issue that the surgeon deems ineffective to the outcome of the study.

Study Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Arms

Treatment

These patients receive the surgery and are followed for two years for outcomes.

Control

These patients do not need and don't receive surgery and are followed for two years to compare to the surgery treatment group

Interventions

Fertilized ACL

Fertilized ACL is an acl reconstruction with Bone marrow aspirate, demineralized bone matrix, and an internal brace.

Primary outcome measure

  • Return to play [ Time Frame: 6 months after surgery until study conclusion ]
  • Biomechanics testing [ Time Frame: 4.5 months after surgery and 6 months after surgery ]

Central Contacts and Locations

Central contacts

chad d lavender, md

304-552-6514doclav@gmail.com

Kara Cipriani, NP

304-541-5316cipriani6@marshall.edu

Locations

Marshall University

Recruiting

Huntington, West Virginia, United States, 25755

Contacts

chad d lavender, md

304-552-6514doclav@gmail.com

Kara Cipriani, np

304-541-5316cipriani6@marshall.edu

More Information

Sponsor

Marshall University

Last update posted

Mar 5, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Marshall University on 2024-03-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.